| Product NDC: | 58914-301 |
| Proprietary Name: | Rectiv |
| Non Proprietary Name: | nitroglycerin |
| Active Ingredient(s): | 4 mg/g & nbsp; nitroglycerin |
| Administration Route(s): | RECTAL |
| Dosage Form(s): | OINTMENT |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 58914-301 |
| Labeler Name: | Aptalis Pharma US, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021359 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20110621 |
| Package NDC: | 58914-301-80 |
| Package Description: | 1 TUBE in 1 CARTON (58914-301-80) > 30 g in 1 TUBE |
| NDC Code | 58914-301-80 |
| Proprietary Name | Rectiv |
| Package Description | 1 TUBE in 1 CARTON (58914-301-80) > 30 g in 1 TUBE |
| Product NDC | 58914-301 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | nitroglycerin |
| Dosage Form Name | OINTMENT |
| Route Name | RECTAL |
| Start Marketing Date | 20110621 |
| Marketing Category Name | NDA |
| Labeler Name | Aptalis Pharma US, Inc. |
| Substance Name | NITROGLYCERIN |
| Strength Number | 4 |
| Strength Unit | mg/g |
| Pharmaceutical Classes | Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] |